MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM— 510(k) K973113

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K973113 for MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM, Substantially Equivalent on 1997-11-10. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1997-08-20
Decision date: 1997-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE

Death: 52
Injury: 2,347
Malfunction: 9,798
Other: 1
Total: 12,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.